Otsuka reported that centanafadine, its investigational ADHD drug, met the primary endpoint in a Phase 3b trial that enrolled 315 adults with attention‑deficit/hyperactivity disorder and comorbid anxiety. Patients who received centanafadine once daily showed an 18.5‑point reduction on the Adult Investigator Symptom Rating Scale after eight weeks, compared with a 12.6‑point decline for placebo. Statistical separation appeared as early as Week 1. The placebo‑adjusted difference of 5.87 points exceeded the effect size seen in two earlier six‑week Phase 3 trials. The study also found a statistically significant 1.92‑point placebo‑adjusted improvement on the Hamilton Anxiety Rating Scale. According to Otsuka’s chief medical officer John Kraus, the data expand evidence for centanafadine’s use “in adults with ADHD across diverse patient presentations.” The company has filed for FDA approval covering children, adolescents, and adults, with an agency decision expected by July 24 and a potential DEA review that could delay launch by about three months.
The Phase 3b outcome reinforces Otsuka’s position as it moves toward the FDA decision window. Demonstrating benefit among patients with anxiety, estimated to affect roughly one‑third of those with ADHD, touches a population often left out of pivotal studies. Approval would place centanafadine in a crowded field but with a distinct mechanism as a norepinephrine, dopamine, and serotonin reuptake inhibitor. The company’s early commercial build‑out already points to operational readiness for launch once regulatory steps clear. Still, the key question is whether Otsuka can turn the modest placebo‑adjusted improvements into real‑world adoption. Payers may weigh outcomes carefully, and clinicians could take a wait‑and‑see approach if the DEA scheduling process stretches into late 2026. For investors, attention stays fixed on the July 24 FDA decision, and on any scheduling details that might shape both timing and competitive stance.
